Overview As a Principal Consultant with an impressive professional career than spans more than 30 years, Jane brings extensive experience and a world of knowledge to MRC Global. This includes senior positions in quality assurance and regulatory affairs for a wide variety of medical device and biomedical companies such as Medtronic.
Jane assists clients in refining and enhancing quality and regulatory systems, processes and protocol. This includes education and training of employees, working with all levels of staff and management to achieve results. From initial audits, analysis and reports to system development, refinement, and enhancement – Jane helps clients create and maintain efficient, effective and compliant quality and regulatory systems.
Propelled by her working knowledge of ISO 13485, ISO 14971, MDD 93/42/EEC, 21 CFR Part 820, ARTG and FDA regulations, she’s an invaluable resource and master at interpreting, navigating and adhering to complex policies and procedures. This not only helps clients maintain quality and regulatory systems, but it also expedites product development and go to market strategies by reducing downstream obstacles.
Jane’s depth of knowledge comes from years of experience developing, managing and leading quality and regulatory systems, departments and teams for some of the industry’s leading medical device and equipment companies. This includes Medtronic, Titan Spine, Gauthier Biomedical, Moore Wallace and Smith & Nephew – one of the world’s leading manufacturers and distributors of medical rehab products.
Adding to her expertise and knowledge, Jane has completed extensive quality, regulatory and compliance training, is a Certified ISO 13485 Auditor and maintains other certifications. Seen as a quality assurance and regulatory affairs authority, Jane is well-respected in the industry as someone who gets results.
